Sr. Quality Engineer

Location: Alachua, FL Annual Bonus Opportunity up to $10,000.00 Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN; Eden Prairie and Glencoe, MN; Neunkirchen, Germany; Glasgow, UK; and Marton, New Zealand. We are proud to be Great Place to Work® Certified in 2026 , reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations. Our comprehensive benefits package includes: Paid Time Off (PTO) 401(k) with up to a 6% company match Holiday pay Medical, dental, and vision insurance Short-term and long-term disability coverage Paid parental leave and much more! Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://www.linkedin.com/company/evergenbio RESPONSIBILITIES Serves as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus Leads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives Other duties as assigned REQUIREMENTS Education Bachelor’s degree in relevant technical discipline Experience 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience. *Combination of advanced degree and experience may be considered. Certification AATB or CTBS Certification, preferred Lead Auditor Certification, preferred ASQ – CQE, CBA, or CQA, preferred Skills Excellent verbal and written communication Technical writing Problem solving methodologies Microsoft Office Suite Quality Management System software Investigations Statistical techniques Travel N/A SAFETY Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or…